EP3191525B1 - Blockierende monoklonale antikörper gegen agr2 und dessen rezeptor c4.4a - Google Patents

Blockierende monoklonale antikörper gegen agr2 und dessen rezeptor c4.4a Download PDF

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EP3191525B1
EP3191525B1 EP15766358.4A EP15766358A EP3191525B1 EP 3191525 B1 EP3191525 B1 EP 3191525B1 EP 15766358 A EP15766358 A EP 15766358A EP 3191525 B1 EP3191525 B1 EP 3191525B1
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cancer
antibody
agr2
cell
seq
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EP3191525A1 (de
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Craig D. Logsdon
Vijaya RAMACHANDRAN
Thiruvengadam Arumugam
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University of Texas System
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    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
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    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
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    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
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    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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    • C07K2317/54—F(ab')2
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    • C07K2317/55—Fab or Fab'
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    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
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    • C07K2317/622—Single chain antibody (scFv)
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    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
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    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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Claims (14)

  1. Isolierter monoklonaler Antikörper oder Antigen-bindendes Fragment davon, wobei der monoklonale Antikörper oder das Antigen-bindende Fragment davon spezifisch an ein AGR2-Polypeptid bindet und umfasst:
    (a) eine erste VH-CDR, die identisch mit SEQ ID Nr. 20 ist;
    (b) eine zweite VH-CDR, die identisch mit SEQ ID Nr. 21 ist;
    (c) eine dritte VH-CDR, die identisch mit SEQ ID Nr. 22 ist;
    (d) eine erste VL-CDR, die identisch mit SEQ ID Nr. 23 ist;
    (e) eine zweite VL-CDR, die identisch mit SEQ ID Nr. 24 ist; und
    (f) eine dritte VL-CDR, die identisch mit SEQ ID Nr. 25 ist.
  2. Isolierter monoklonaler Antikörper oder Antigen-bindendes Fragment davon nach Anspruch 1,
    (i) wobei der isolierte monoklonale Antikörper oder das Antigen-bindende Fragment umfasst:
    (a) eine erste VH-CDR, die identisch mit SEQ ID Nr. 20 ist;
    (b) eine zweite VH-CDR, die identisch mit SEQ ID Nr. 21 ist;
    (c) eine dritte VH-CDR, die identisch mit SEQ ID Nr. 22 ist; und
    (d) eine VL-Domäne, die identisch mit SEQ ID Nr. 19 ist;
    oder
    ii) wobei der isolierte monoklonale Antikörper oder das Antigen-bindende Fragment davon umfasst:
    (a) eine VH-Domäne, die identisch mit SEQ ID Nr. 18 ist;
    (b) eine erste VL-CDR, die identisch mit SEQ ID Nr. 23 ist;
    (c) eine zweite VL-CDR, die identisch mit SEQ ID Nr. 24 ist; und
    (d) eine dritte VL-CDR, die identisch mit SEQ ID Nr. 25 ist;
    oder
    (iii) wobei der isolierte monoklonale Antikörper oder das Antigen-bindende Fragment davon umfasst:
    eine VH-Domäne, die zu mindestens 80 % identisch mit der VH-Domäne von SEQ ID Nr. 18 ist, und
    eine VL-Domäne, die zu mindestens 80 % identisch mit der VL-Domäne von SEQ ID Nr. 19 ist;
    oder
    (iv) wobei der isolierte monoklonale Antikörper oder das Antigen-bindende Fragment davon umfasst:
    eine VH-Domäne, die identisch mit der VH-Domäne von SEQ ID Nr. 18 ist, und
    eine VL-Domäne, die identisch mit der VL-Domäne von SEQ ID Nr. 19 ist.
  3. Isolierter monoklonaler Antikörper oder Antigen-bindendes Fragment davon nach Anspruch 1 oder Anspruch 2,
    wobei der Antikörper rekombinant ist; oder
    wobei der Antikörper ein IgG, IgM, IgA oder ein Antigen-bindendes Fragment davon ist; oder
    wobei der Antikörper ein Fab', ein F(ab')2, ein F(ab')3, ein einwertiger scFv oder ein zweiwertiger scFv ist; oder
    wobei der Antikörper ein humanisierter Antikörper oder deimmunisierter Antikörper ist; oder
    wobei der Antikörper an ein Bildgebungsmittel, ein Chemotherapeutikum, ein Toxin oder ein Radionuklid konjugiert ist.
  4. Pharmazeutische Zusammensetzung umfassend den isolierten monoklonalen Antikörper oder das Antigen-bindende Fragment davon nach einem der Ansprüche 1-3 und einen pharmazeutisch oder physiologisch verträglichen Träger oder Hilfsstoff.
  5. Polynukleotid-Molekül umfassend eine Nukleinsäuresequenz, die einen monoklonalen Antikörper nach einem der Ansprüche 1-3 kodiert.
  6. Wirtszelle umfassend ein oder mehrere Polynukleotid-Molekül(e), das/die einen isolierten monoklonalen Antikörper nach einem der Ansprüche 1-3 kodiert/kodieren, wahlweise, wobei die Wirtszelle eine Säugetierzelle, eine Hefezelle, eine Bakterienzelle, eine Ciliatenzelle oder eine Insektenzelle ist.
  7. Verfahren zur Herstellung eines Antikörpers, umfassend:
    a) Exprimieren eines oder mehrerer Polynukleotid-Molekül(e), das/die eine VL- und VH-Kette eines isolierten monoklonalen Antikörpers nach einem der Ansprüche 1-3 in einer Zelle kodiert/kodieren; und
    b) Reinigen des Antikörpers aus der Zelle.
  8. Isolierter monoklonaler Antikörper oder Antigen-bindendes Fragment davon nach einem der Ansprüche 1-3, oder pharmazeutische Zusammensetzung nach Anspruch 4, zur Verwendung beim Behandeln von Krebs bei einem Subjekt.
  9. Isolierter monoklonaler Antikörper oder Antigen-bindendes Fragment davon zur Verwendung nach Anspruch 8, wobei der Krebs ein Brustkrebs, Lungenkrebs, Kopf- und Halskrebs, Prostatakrebs, Speiseröhrenkrebs, Luftröhrenkrebs, Hautkrebs, Hirnkrebs, Leberkrebs, Blasenkrebs, Magenkrebs, Pankreaskrebs, pankreatisches Duktaladenokarzinom, Eierstockkrebs, Gebärmutterkrebs, Gebärmutterhalskrebs, Hodenkrebs, Kolonkrebs, Rektumkrebs oder Hautkrebs ist.
  10. Isolierter monoklonaler Antikörper oder Antigen-bindendes Fragment davon zur Verwendung nach Anspruch 8 oder 9,
    wobei der isolierte monoklonale Antikörper oder das Antigen-bindende Fragment davon systemisch verabreicht wird; oder
    wobei der isolierte monoklonale Antikörper oder das Antigen-bindende Fragment davon intravenös, intradermal, intratumoral, intramuskulär, intraperitoneal, subkutan oder lokal verabreicht wird; oder
    wobei die Behandlung ferner das Verabreichen mindestens einer zweiten Antikrebstherapie an das Subjekt umfasst; wahlweise
    wobei die zweite Antikrebstherapie eine chirurgische Therapie, Chemotherapie, Strahlentherapie, Kryotherapie, hormonale Therapie, Immuntherapie oder Zytokintherapie ist; oder
    wobei das Subjekt ein menschliches Subjekt ist.
  11. Zusammensetzung, umfassend den isolierten monoklonalen Antikörper nach Anspruch 1-3 zur Verwendung bei der Behandlung eines Krebses bei einem Patienten.
  12. Zusammensetzung zur Verwendung nach Anspruch 11, ferner umfassend einen C4.4A-bindenden Antikörper.
  13. Zusammensetzung zur Verwendung nach Anspruch 12,
    wobei der C4.4A-bindende Antikörper ein monoklonaler Antikörper oder ein Antigen-bindendes Fragment davon, ein polyklonaler Antikörper, ein chimärer Antikörper, ein affinitätsgereifter Antikörper, ein humanisierter Antikörper oder ein Antigen-bindendes Antikörperfragment ist; oder
    wobei das Antigen-bindende Fragment davon ein Fab, Fab', Fab'-SH, F(ab')2 oder scFv ist; oder
    wobei der C4.4A-bindende Antikörper an ein Mittel angehängt ist, das auf eine C4.4A-exprimierende Zelle abzuzielen ist, und wahlweise, wobei das Mittel ein zytotoxisches Mittel, ein Zytokin, ein anti-angiogenes Mittel, ein Chemotherapeutikum, ein diagnostisches Mittel, ein Bildgebungsmittel, ein Radioisotop, ein proapoptotisches Mittel, ein Enzym, ein Hormon, ein Wachstumsfaktor, ein Peptid, ein Protein, ein Antibiotikum, ein Antikörper, ein Fab-Fragment eines Antikörpers, ein Antigen, ein Überlebensfaktor, ein anti-apoptotisches Mittel, ein Hormonantagonist, ein Virus, ein Bakteriophage, ein Bakterium, ein Liposom, ein Mikropartikel, ein Nanopartikel, ein Magnetkügelchen, eine Mikrovorrichtung, eine Zelle, eine Nukleinsäure oder ein Expressionsvektor ist; oder
    wobei der C4.4A-bindende Antikörper für systemische, intravenöse, intradermale, intratumorale, intramuskuläre, intraperitoneale, subkutane oder lokale Verabreichung bei der Behandlung von Krebs bei einem Patienten formuliert ist; oder
    wobei der Krebs ein Brustkrebs, Lungenkrebs, Kopf- und Halskrebs, Prostatakrebs, Speiseröhrenkrebs, Luftröhrenkrebs, Hautkrebs, Hirnkrebs, Leberkrebs, Blasenkrebs, Magenkrebs, Pankreaskrebs, pankreatisches Duktaladenokarzinom, Eierstockkrebs, Gebärmutterkrebs, Gebärmutterhalskrebs, Hodenkrebs, Kolonkrebs, Rektumkrebs oder Hautkrebs ist; oder
    wobei bei dem Patienten zuvor festgestellt wurde, dass er ein pankreatisches Duktaladenokarzinom hat; oder
    wobei die Behandlung ferner das Verabreichen mindestens eines zweiten Antikrebsmittels umfasst, wahlweise, wobei das zweite Antikrebsmittel ein Chemotherapeutikum, Hormon, Immuntherapeutikum oder Zytokin ist.
  14. Kit umfassend den isolierten monoklonalen Antikörper nach einem der Ansprüche 1-3.
EP15766358.4A 2014-09-09 2015-09-08 Blockierende monoklonale antikörper gegen agr2 und dessen rezeptor c4.4a Not-in-force EP3191525B1 (de)

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US201462048037P 2014-09-09 2014-09-09
PCT/US2015/048936 WO2016040321A1 (en) 2014-09-09 2015-09-08 Blocking monoclonal antibodies to agr2 and its receptor c4.4a

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EP3191525A1 EP3191525A1 (de) 2017-07-19
EP3191525B1 true EP3191525B1 (de) 2019-08-28

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US (1) US10428159B2 (de)
EP (1) EP3191525B1 (de)
JP (1) JP2017534251A (de)
KR (1) KR20170058960A (de)
CN (1) CN107074940A (de)
AU (1) AU2015315332A1 (de)
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EP3986426A4 (de) * 2019-06-21 2023-10-18 Board of Regents, The University of Texas System Targeting von alpha3beta1-integrin zur behandlung von krebs und anderen erkrankungen
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CA2960499A1 (en) 2016-03-17
JP2017534251A (ja) 2017-11-24
CN107074940A (zh) 2017-08-18
AU2015315332A1 (en) 2017-03-30
KR20170058960A (ko) 2017-05-29
EP3191525A1 (de) 2017-07-19
BR112017004510A2 (pt) 2018-01-23
BR112017004510A8 (pt) 2018-06-26
US10428159B2 (en) 2019-10-01
US20170283509A1 (en) 2017-10-05

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